Comp in-vitro disso studies for generics in India [Dissolution / BCS / IVIVC]

posted by jag009  – NJ, 2020-03-15 07:25  – Posting: # 21271
Views: 856

Hi,

» I know the US rules but not if it's the same as in India...
»
» Please let us know the US rules.

In terms of disso, for US you have to follow the FDA recommended dissolution method listed for the designated reference product. If there is no FDA method then you use the USP method.


Thx
J

Complete thread:

Activity
 Admin contact
20,458 posts in 4,296 threads, 1,414 registered users;
online 9 (1 registered, 8 guests [including 1 identified bots]).
Forum time (Europe/Vienna): 17:11 CEST

Genius is that which forces
the inertia of humanity to learn.    Henri Bergson

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5